Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55

Product NDC: 36800-167
11-digit product format: 368000167
Labeler code: 36800
Product ID: 36800-167_2487df86-039b-4d33-e063-6394a90acb50
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: TOPCO ASSOCIATES LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-24
Substance: OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE
Active strength: 70; 50; 100; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	36800-167		D	Discontinued by firm		2026-11-03
excluded package	package	36800-167	36800-167-08	D	Discontinued by firm		2026-11-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-167-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-167-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-167-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-167-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-167-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-167-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-167-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-167-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-167-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-167-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-167-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-167-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	70 mg/mL
OCTISALATE	50 mg/mL
HOMOSALATE	100 mg/mL
AVOBENZONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c6268778-8dcc-24b6-e053-2995a90acf03	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-167-09	Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55	89 mL in 1 TUBE	LOTION	89		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-167	TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 55 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [TOPCO ASSOCIATES LLC]	2	Current NDC, Legacy NDC, 1 package rows	20241017_c6268778-8dcc-24b6-e053-2995a90acf03.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 264 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted	ZINC OXIDE	Allure Labs	02f9c859-8d7d-5146-e063-6394a90a57b5	2024-12-09	Warnings	Exact identifier application number: M020
Quench and Protect Hydrating SPF30	ZINC DIOXIDE AND TITANIUM DIOXIDE	Allure Labs.	039e50c1-7b3d-d392-e063-6394a90a4b3c	2024-12-09	Warnings	Exact identifier application number: M020
Tinted Face Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	0d7300ee-adf4-41be-bb9f-257cd2986c0f	2024-12-06	Warnings	Exact identifier application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Beautcella Inc.	bad942d8-04da-31d2-e053-2a95a90a9275	2024-12-06	Warnings	Exact identifier application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	289b824f-bb0b-313e-e063-6394a90ab783	2024-12-06	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d840001-a648-df1b-e063-6294a90ab299	2024-12-06	Warnings	Exact identifier application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE, OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	1629f061-b8fc-4fda-8378-c64e164d41bd	2024-12-06	Warnings	Exact identifier application number: M020
Clear System Brightening Day Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	8cbc8fa4-469f-4fa3-bd8e-27e815989c3f	2024-12-06	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	604e7a49-7986-11ee-e053-2a91aa0a1bee	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 27	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	c4e16cec-c7db-4e5e-9d05-5d7afdb79091	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB SPF42 No29	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3fc90114-4cdf-273e-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 31	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95862d15-d977-7276-e053-2995a90ab690	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB Cream SPF42 No. 25	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9c6f48b1-007b-434f-b756-242e3390e9b7	2024-12-05	Warnings	Exact identifier application number: M020
MISSHA ALL AROUND VITA C SUNSCREEN	ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	1a7ec673-328a-8924-e063-6294a90a2f3d	2024-12-05	Warnings	Exact identifier application number: M020
(Re)Setting Refreshing Mist SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	d4d8f28d-cb00-298d-e053-2995a90a10eb	2024-12-05	Warnings	Exact identifier application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	2ba71f81-54d0-4955-9bae-2b6e35c9c35f	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Glow Body SPF 45	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	db5f6bad-65ae-2b05-e053-2a95a90a8569	2024-12-05	Warnings	Exact identifier application number: M020
Cay Skin Isle Glow Face SPF 45	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Cay Skin, Inc.	d91bba06-fd9b-3eb5-e053-2995a90a6124	2024-12-05	Warnings	Exact identifier application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	65de9491-8804-4e3b-90a7-9b253e34b7d3	2024-12-05	Warnings	Exact identifier application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlight	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	499e5352-fcc4-4434-96f2-4375816991c9	2024-12-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-167-09	36800016709	89 mL in 1 TUBE (36800-167-09)	89 ml	2019-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topcare Everyday Ultimate Sheer Sun Lotion Broad Spectrum SPF 55	TOPCO ASSOCIATES LLC	2024-10-15	HUMAN OTC DRUG LABEL	2